Regeneron Pharmaceuticals Inc - REGN STOCK NEWS

Regeneron Pharmaceuticals announced positive three-year data for EYLEA HD® (aflibercept) Injection 8 mg from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (DME). Key findings include:

- 88% of EYLEA HD patients maintained ≥12-week dosing intervals at week 156
- 48% achieved ≥20-week dosing intervals
- Sustained visual gains and anatomic improvements from year two
- Patients switched from EYLEA® 2 mg to EYLEA HD experienced slower fluid reaccumulation
- 83% of switched patients maintained ≥12-week dosing intervals

The safety profile remained consistent with known EYLEA HD and EYLEA profiles. These results support EYLEA HD's longer duration of action and potential for reduced treatment burden in DME patients.

Regeneron Pharmaceuticals and Sanofi announced that the FDA has approved Dupixent® (dupilumab) as the first-ever biologic medicine for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. This approval follows recent approvals in the EU and China.

The approval is based on two Phase 3 trials (BOREAS and NOTUS) that showed Dupixent significantly reduced exacerbations, improved lung function, and enhanced health-related quality of life compared to placebo. Key results include:

• 30-34% reduction in moderate or severe COPD exacerbations
• 68-74mL improvements in post-bronchodilator FEV1
• 51% response in health-related quality of life measure

Dupixent is now indicated for approximately 300,000 adults in the U.S. with this specific COPD phenotype. The FDA evaluated Dupixent under Priority Review, recognizing its potential significant improvements in efficacy or safety for treating serious conditions.

Regeneron Pharmaceuticals and Sanofi announced that China's National Medical Products Administration (NMPA) has approved Dupixent® (dupilumab) for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. The approval is based on two Phase 3 trials, BOREAS and NOTUS, which showed Dupixent significantly reduced COPD exacerbations by 30% and 34% respectively, improved lung function, and enhanced quality of life compared to placebo.

COPD is the most prevalent chronic respiratory disease in China, affecting one in four people with COPD worldwide. The approval of Dupixent fills a gap in targeted therapy for COPD patients who remain inadequately controlled even after triple therapy. Dupixent is now approved in four indications across respiratory and dermatological diseases in China, and in more than 30 countries worldwide for COPD treatment.

Regeneron Pharmaceuticals (NASDAQ: REGN) has announced it will report its third quarter 2024 financial and operating results on Thursday, October 31, 2024, before the U.S. financial markets open. The company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time on the same day.

Participants can access the conference call via webcast on Regeneron's website or by telephone after registering in advance. A replay and transcript of the call will be archived on the company's website for at least 30 days.

Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency's CHMP has recommended the expanded approval of Dupixent® (dupilumab) in the EU for eosinophilic esophagitis (EoE) in children aged 1 to 11 years. The recommendation is based on a Phase 3 trial showing significantly greater histological remission in children treated with Dupixent compared to placebo. If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group.

The trial demonstrated sustained results for up to one year, with caregivers observing improvements in EoE signs and symptoms. The safety profile was consistent with that observed in adolescents and adults. The European Commission is expected to make a final decision in the coming months.

Regeneron Pharmaceuticals and Sanofi announced FDA approval of Dupixent® (dupilumab) for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This expands the 2019 approval for adults. The FDA granted Priority Review, recognizing potential significant improvements in treating this serious condition.

CRSwNP affects about 9,000 adolescents in the U.S., causing breathing difficulties and reduced quality of life. Dupixent, as an add-on maintenance treatment, offers an alternative to systemic steroids and surgery, which often result in symptom recurrence.

The approval is based on positive results from two pivotal trials in adults (SINUS-24 and SINUS-52), showing significant improvements in nasal congestion, polyp size, and smell. Safety profile in adolescents is consistent with that observed in adults.

Regeneron Pharmaceuticals (NASDAQ: REGN) announced new analyses of EYLEA HD® (aflibercept) Injection 8 mg and EYLEA® (aflibercept) Injection 2 mg to be presented at EURETINA 2024. The data reinforces EYLEA HD's long-term durability, sustained fluid control, and safety profile in wet age-related macular degeneration (wAMD) patients. Key highlights include:

1. Analysis of extended dosing intervals impact
2. Evaluation of sustained fluid control over two years
3. Safety analysis of intraocular pressure outcomes through week 96
4. Indirect comparison with faricimab across different Phase 3 trials

The presentations support EYLEA HD's efficacy, safety, and potential to become the new standard of care for retinal diseases. Additional data on diabetic macular edema and pooled safety analysis will also be shared.

Regeneron Pharmaceuticals and Sanofi announced positive results from a confirmatory Phase 3 trial (LIBERTY-CUPID Study C) of Dupixent for treating chronic spontaneous urticaria (CSU). The trial met primary and key secondary endpoints, showing:

- Nearly 50% reduction in itch and urticaria activity scores compared to placebo
- 30% of Dupixent-treated patients reported no urticaria vs 18% on placebo
- Safety results consistent with Dupixent's known profile

These results confirm findings from Study A. Regeneron plans to submit data to the FDA by year-end 2024 for potential U.S. approval. If approved, Dupixent would be the first targeted CSU therapy in a decade, potentially benefiting over 300,000 people in the U.S. with inadequately controlled CSU.

Regeneron Pharmaceuticals and Sanofi announced positive results from a pivotal trial of Dupixent (dupilumab) in adults with moderate-to-severe bullous pemphigoid (BP). The trial met its primary and all key secondary endpoints, with five times more Dupixent patients achieving sustained disease remission compared to placebo. Notably, 20% of Dupixent patients experienced sustained disease remission at 36 weeks versus 4% for placebo.

Dupixent showed significant improvements in disease severity, itch reduction, and decreased oral corticosteroid use. If approved, it would be the first targeted medicine for BP in the U.S. and EU. The drug's safety profile was consistent with previous studies. These results support upcoming regulatory submissions, starting with the U.S. later this year.